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SHAPE (Phase 2, Parkinsons disease dementia and dementia with Lewy bodies, December 2023)

Constitutional grants are provided by law and not policy

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"Further, while we acknowledge the corrective and preventive actions that your site has taken or plans to take, your written response is inadequate because it does not provide sufficient details about how you, as a clinical investigator, will ensure adequate oversight of the study procedures (for example, adherence to eligibility requirements)

Nevertheless, pathways implicated in preclinical studies, including angiogenesis, inflammatory modulation, and collagen remodeling, intersect with biologic systems central to incision healing and complication avoidance, although these mechanistic signals have not been shown to translate into improved clinical outcomes

This value was much higher than the 4 to 6 nm range reported by Spanhel et al